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Anti-Infective Completed with Results

Study to evaluate inhaled AP-PA02 in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (Armata Phase 1b/2) (Armata AP-PA02-101)

This study looked at the safety and tolerability of inhaled AP-PA02, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill specific bacterial strains. Multiple doses of the drug were tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa to find the best dose.

 This study had two parts: In part 1, participants received a single dose of phage or placebo (SAD) and in Part 2, participants received multiple doses of either phage or placebo (MAD). During Part 2, the dose level of phage given was increased for each successively enrolled group of patients; the first group received phage or placebo 3 times a day for 3 days, the next group received phage or placebo 2 times a day for 5 days, the last group received phage or placebo 2 times a day for 10 days. Researchers monitored safety and evaluated the phage’s effect by measuring how much P. aeruginosa was in participants’ sputum.

Eligibility

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Study Results

  • What We Learned:

    AP-PA02 was generally safe and well-tolerated, and trends were observed that suggested an effect on P. aeruginosa at the highest doses tested. 

  • Primary Findings:

    Effectiveness:

    The study was conducted between November 2021 and December 2022. Twenty-nine participants were enrolled in the study, and all completed the study.   

     

    A company press release noted a trend toward reduction of P. aeruginosa was observed in the highest dose group.  

    Safety:

    All doses of AP-PA02 were well tolerated with the proportion of participants with an adverse event similar between the phage treatment groups and placebo.  (Data from clinicaltrials.gov)

     

    Results have not been peer-reviewed and come from https://clinicaltrials.gov/study/NCT04596319 

  • Citation:

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    38 days

  • Number of Study Visits:

    8

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Armata

  • Study Drugs:

    AP-PA02

Eligibility

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40% or greater

  • Pseudomonas Status:

    Positive Respiratory Cultures Required

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

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